Senior QA Validation Specialist: cGMP Quality Lead

Lonza; Geleen; On-site; Confidential; Full time

Benefits offered by this job

Agile career culture

Inclusive workplace

Performance-based compensation

Role/location-based benefits

Continuous improvement initiatives

Interface with QA/Engineering/Manufact

Job summary

Lonza Geleen seeks a Sr. QA Validation Specialist to lead validation for equipment, facilities and utilities, ensuring compliance with cGMP and regulatory standards.

You will oversee documentation, qualification activities and support cross-functional teams in Engineering and Manufacturing to maintain high quality production. This site-based role offers opportunities to influence validation processes, participate in continuous improvement and contribute to global quality standardization within a

Qualifications

• 5–10 years of experience in validation, quality assurance, or related area within a regulated manufacturing environment.
• Bachelor’s or Master’s degree in Engineering, Biology, Biomedical Science, Life Science or related discipline.
• Experience with cGMP, GxP, GAMP and related quality systems, with knowledge of European and FDA expectations.

Responsibilities

• Oversee qualification and validation activities for equipment, facilities and utilities, ensuring deliverables meet quality and regulatory requirements.
• Review and approve validation documentation (URs, validation plans, design/qualification docs, commissioning, factory/site acceptances).
• Ensure traceability of requirements from URs to performance qualification.
• Assess validation impact and support periodic reviews of validated assets and changes.
• Manage validation deviations and changes with proper documentation and actions.
• Provide quality and compliance support to Engineering, Manufacturing and Technical Services teams.
• Contribute to continuous improvement and standardization of validation processes across the organization.

Skills

Analytical skills

Problem-solving

Communication skills

Time-management

Cross-functional collaboration

Education

Bachelor’s/Master’s in Engineering or Life Sciences

Job description

Lonza Geleen seeks a Sr. QA Validation Specialist to lead validation for equipment, facilities and utilities, ensuring compliance with cGMP and regulatory standards.

You will oversee documentation, qualification activities and support cross-functional teams in Engineering and Manufacturing to maintain high quality production. This site-based role offers opportunities to influence validation processes, participate in continuous improvement and contribute to global quality standardization within a